What are clinical trials?

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    Medicines,  €    100 Medical devices,    ‚  Vaccines,   

In a clinical trial, doctors and other sta give treatments to volunteers based on a specific plan. Experts review this plan to make sure volunteers are safe. volunteers

Researchers must give volunteers complete information about the clinical trial before they agree to take part. This is called informed consent. Volunteers can leave the trial at any time.

volunteers in clinical trials worldwide in 2015 131 , 749 40 , 835 of those volunteers were in the U.S.

Clinical trials take place all over the nation and are sponsored by many types of organizations, such as the government, hospitals, drug companies, and research centers.

Phases allow careful testing of new possible treatments. Each phase answers dierent and important questions.

Phase 1

Phase 2

Phase 3   

Phase 4   



  



of volunteers 1000s

100s of volunteers

10s of volunteers

Countless volunteers

FDA Approval

 Is it safe for people? How much of the treatment is needed?



 Does it work better than the current treatment? Are there new safety concerns?

 Does it work for all types of people? Are there new safety concerns?

How well does it work? Are there new safety concerns?

 

www.fda.gov/AboutFDA/Transparency/ Sources: www.fda.gov/downloads/Drugs/InformationOnDrugs/

Interested in volunteering for a clinical trial? Visit: www.melanoma.org/clinical-trials